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Method for determining content of conivaptan hydrochloride by virtue of high performance liquid chromatography

A technology of conivaptan hydrochloride and high performance liquid chromatography, applied in the field of drug analysis, can solve the problems of increased labor, cumbersome operation, high toxicity, etc., achieves high accuracy and sensitivity, solves content instability and reproducibility Good results

Inactive Publication Date: 2017-02-22
蚌埠丰原涂山制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Reagents such as formic acid, glacial acetic acid, mercuric acetate, and perchloric acid are used in this method, which are relatively toxic, and the operation is also cumbersome, especially for the simultaneous detection of multiple batches of raw materials, and the labor load is doubled.

Method used

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  • Method for determining content of conivaptan hydrochloride by virtue of high performance liquid chromatography
  • Method for determining content of conivaptan hydrochloride by virtue of high performance liquid chromatography
  • Method for determining content of conivaptan hydrochloride by virtue of high performance liquid chromatography

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0066] The selection of experimental example 1 maximum absorption wavelength and chromatographic conditions

[0067] Get conivaptan hydrochloride crude drug, add methyl alcohol and make the solution that contains the conivaptan hydrochloride of 20 μ g about in every 1 milliliter of methanol, measure according to ultraviolet spectrophotometry (two appendix IV A of Chinese Pharmacopoeia 2010 edition), at 200- Wavelength scanning was carried out in the wavelength range of 400nm, and the test results are shown in Table 1 below.

[0068] Table 1 Wavelength scan results

[0069]

[0070]

[0071] The test results show that the methanol solution of this product has maximum absorption at wavelengths of 204nm±2nm, 241nm±2nm, and 276nm±2nm, and the ultraviolet absorption spectrum of the sample is consistent with that of the reference substance. Considering that 204nm is more susceptible to interference and 276nm absorption peak is not obvious, it is preferred to use 240nm as the ...

experiment example 2

[0072] Experimental example 2 specificity

[0073] a, reference substance solution: take about 20 mg of conivaptan hydrochloride reference substance (batch number: 20130223), accurately weighed, put in a 100mL measuring bottle, add solvent (i.e. acetonitrile-phosphate buffer, the volume ratio of acetonitrile to phosphate buffer 57:43) dissolved and diluted to the mark, shake well, that is.

[0074] b. The test solution: take about 20 mg of this product (batch number: 20130129), weigh it accurately, put it in a 100 mL measuring bottle, add solvent to dissolve and dilute to the mark, shake well, and you get it.

[0075] Get each 10 μ L of solvent, reference substance solution, and need testing solution and inject high performance liquid chromatograph, record chromatogram (see respectively Figure 1-3 ); The result shows that need testing solution and reference substance solution go out peak at identical position, and solvent does not produce any chromatographic peak at this pos...

experiment example 3

[0076] Experimental Example 3 Linearity and Range

[0077] Take 50.12 mg of conivaptan hydrochloride reference substance dried to constant weight, accurately weighed, put in a 25mL measuring bottle, dissolve and dilute to the mark with a solvent, shake well, and use it as the reference substance stock solution; accurately measure the reference substance stock solution Put 0.4mL, 0.8mL, 1.0mL, 1.2mL, 1.4mL and 1.6mL into 10mL measuring bottles respectively, add solvent to dilute to the mark, shake well, and under the above chromatographic conditions, accurately measure 10 μL of each solution and inject into high performance liquid chromatography Instrument, record chromatogram; With injection concentration (mg / mL) as X, conivaptan hydrochloride peak area (A) as Y, make linear regression equation, result is as follows table 2. Figure 4 Conivaptan hydrochloride standard curve.

[0078] Table 2 Preparation of Conivaptan Hydrochloride Content Determination Standard Curve

[0079...

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Abstract

The invention provides a method for determining the content of conivaptan hydrochloride by virtue of a high performance liquid chromatography. The method comprises the following chromatographic conditions: a mobile phase A is acetonitrile, a mobile phase B is a phosphate buffer solution, the concentration of sodium dihydrogen phosphate in the phosphate buffer solution is 0.02mol / L, the mass concentration of sodium lauryl sulfate in the phosphate buffer solution is 0.5%, and the pH value of the phosphate buffer solution is 2.8-3.2. By virtue of the method, the content of a conivaptan hydrochloride raw material drug can be effectively determined, and the method is high in accuracy and sensitivity and good in repeatability. Compared with a traditional method, the method has the characteristics of high efficiency and accuracy.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for determining the content of conivaptan hydrochloride crude drug by using high performance liquid chromatography. Background technique [0002] The chemical name of conivaptan hydrochloride is N-{4-[(2-methyl-4,5-dihydroimidazo[4,5-d][1]-benzazepine-6(1H) -yl)carbonyl]phenyl}biphenyl-2-carboxamide hydrochloride, the CAS number is 168626-94-6, and the English name is Conivaptan Hydrochloride. Conivaptan hydrochloride is a non-peptide dual inhibitor of arginine vasopressin (AVP) V1a and V2 receptors. FDA approved the listing of Conivaptan Hydrochloride of Astellas Pharma US Company the earliest on December 29, 2005, the trade name Vaprisol, is the injection of 20mg / 4mL, and its indication is mainly used for the hyponatremia of normal blood volume (often Patients with syndrome of inappropriate secretion of antidiuretic hormone, patients with hypothyroidism, patien...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N21/33
CPCG01N30/02G01N21/33G01N2030/027
Inventor 张良林
Owner 蚌埠丰原涂山制药有限公司
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